Retinal DetachmentMethotrexateNCT07058337
Methotrexate in Retinal Detachment With Proliferative Vitreoretinopathy
A study testing parsplana vitrectomy and adjunctive use of Methotrexate in people with Retinal Detachment, run by Benha University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the efficacy and safety of intraocular methotrexate (MTX) in preventing and managing proliferative vitreoretinopathy (PVR) in patients undergoing retinal detachment surgery Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- parsplana vitrectomy and adjunctive use of Methotrexate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Jun 2024to 9 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years and older.
- Diagnosed with RRD with clinical signs of PVR.
- No history of prior ocular surgeries for RRD or PVR.
Who cannot join
- Patients with other retinal diseases (e.g., diabetic retinopathy or retinal vascular occlusions).
- Individuals with significant systemic illnesses that could influence surgical outcomes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Methotrexate as an Adjunct to Parsplana Vitrectomy for the Preventing and Treatment of Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment: A Clinical Study
The aim of this study is to evaluate the efficacy and safety of intraocular methotrexate (MTX) in preventing and managing proliferative vitreoretinopathy (PVR) in patients undergoing retinal detachment surgery
Read the detailed description
Patients will be randomized into two groups if clinical evidence of PVR is detected at the time of surgery, utilizing a computer-generated list for randomization. All surgeries will be conducted by the same surgeon to maintain consistency in technique.
Intervention Groups:
- Group 1 (PPV Alone): Patients in this group will undergo pars plana vitrectomy (PPV) only.
Group 2 (PPV with Methotrexate): Patients in this group will receive complete PPV along with adjunctive intravitreal methotrexate.
- Conditions
- Retinal Detachment
- Being tested
- parsplana vitrectomy, adjunctive use of Methotrexate
- Keywords
- Proliferative Vitreoretinopathy, Rhegmatogenous Retinal Detachment, Methotrexate
- Medical subject headings
- Retinal Detachment, Vitreoretinopathy, Proliferative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parsplana vitrectomyProcedure or surgery
23 gauge parsplana vitrectomy
adjunctive use of MethotrexateProcedure or surgery
intravitreal methotrexate (200 μg/0.05 ml) at the time of surgery and repeated weekly for four weeks postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (PPV Alone) | Active comparator | Patients in this group will undergo pars plana vitrectomy (PPV) only. Receives: Procedure: parsplana vitrectomy |
| Group 2 (PPV with Methotrexate) | Active comparator | Patients in this group will receive complete PPV along with adjunctive intravitreal methotrexate Receives: Procedure: parsplana vitrectomy; Procedure: adjunctive use of Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Best-Corrected Visual Acuity (BCVA):
BCVA will be measured using the logarithm of the minimum angle of resolution (LogMAR) scale. A LogMAR value of 0.0 corresponds to normal visual acuity (Snellen equivalent 6/6 or 20/20), representing the ability to resolve an optotype that subtends 5 minutes of arc. Visual acuity will be converted to LogMAR values for statistical analysis.
Measured: 3 and 6 months after tamponade removal
Anatomical Success
Successful Retinal Reattachment:
Defined as complete reattachment of the neurosensory retina to the underlying retinal pigment epithelium (RPE) without persistent or recurrent subretinal fluid at the final follow-up visit, as confirmed by clinical examination and optical coherence tomography (OCT), in the absence of tamponade or additional surgical intervention.
Measured: within 6 months after tamponade removal
Number of Operations Required
The total number of surgical procedures (including vitrectomy, scleral buckling, retinopexy, or tamponade exchange) required to achieve and maintain retinal reattachment will be recorded for each eye.
Measured: within 6 months after tamponade removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start9 Jun 2024
- Primary completion1 Jun 2025
- Study completion9 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Mohamed Elsayed Mohamed Saad, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058337
- Sponsor's protocol ID
- Methorexate in PVR
- Acronym
- Methotrexate
- Status last verified
- Jul 2025
- First submitted
- 28 Apr 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methotrexate as an Adjunct to Parsplana Vitrectomy for the Preventing and Treatment of Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment: A Clinical Study
- ClinicalTrials.gov ID
- NCT07058337
- Acronym / sponsor ID
- Methotrexate / Methorexate in PVR
- Conditions
- Retinal Detachment
- Keywords
- Proliferative Vitreoretinopathy, Rhegmatogenous Retinal Detachment, Methotrexate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 9 Jun 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 9 Jun 2025 (actual)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the efficacy and safety of intraocular methotrexate (MTX) in preventing and managing proliferative vitreoretinopathy (PVR) in patients undergoing retinal detachment surgery
Detailed description
Patients will be randomized into two groups if clinical evidence of PVR is detected at the time of surgery, utilizing a computer-generated list for randomization. All surgeries will be conducted by the same surgeon to maintain consistency in technique.
Intervention Groups:
- Group 1 (PPV Alone): Patients in this group will undergo pars plana vitrectomy (PPV) only.
Group 2 (PPV with Methotrexate): Patients in this group will receive complete PPV along with adjunctive intravitreal methotrexate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (PPV Alone) | Active comparator | Procedure: parsplana vitrectomyPatients in this group will undergo pars plana vitrectomy (PPV) only. |
| Group 2 (PPV with Methotrexate) | Active comparator | Procedure: parsplana vitrectomy, Procedure: adjunctive use of MethotrexatePatients in this group will receive complete PPV along with adjunctive intravitreal methotrexate |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 years and older.
- Diagnosed with RRD with clinical signs of PVR.
- No history of prior ocular surgeries for RRD or PVR.
Key exclusion criteria (2 listed)
- Patients with other retinal diseases (e.g., diabetic retinopathy or retinal vascular occlusions).
- Individuals with significant systemic illnesses that could influence surgical outcomes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| parsplana vitrectomy23 gauge parsplana vitrectomy | Procedure or surgery | Group 1 (PPV Alone), Group 2 (PPV with Methotrexate) |
| adjunctive use of Methotrexateintravitreal methotrexate (200 μg/0.05 ml) at the time of surgery and repeated weekly for four weeks postoperatively | Procedure or surgery | Group 2 (PPV with Methotrexate) |
Primary outcome
Visual Acuity
Time frame: 3 and 6 months after tamponade removal
Best-Corrected Visual Acuity (BCVA): BCVA will be measured using the logarithm of the minimum angle of resolution (LogMAR) scale. A LogMAR value of 0.0 corresponds to normal visual acuity (Snellen equivalent 6/6 or 20/20), representing the ability to resolve an optotype that subtends 5 minutes of arc. Visual acuity will be converted to LogMAR values for statistical analysis.
Anatomical Success
Time frame: within 6 months after tamponade removal
Successful Retinal Reattachment: Defined as complete reattachment of the neurosensory retina to the underlying retinal pigment epithelium (RPE) without persistent or recurrent subretinal fluid at the final follow-up visit, as confirmed by clinical examination and optical coherence tomography (OCT), in the absence of tamponade or additional surgical intervention.
Number of Operations Required
Time frame: within 6 months after tamponade removal
The total number of surgical procedures (including vitrectomy, scleral buckling, retinopexy, or tamponade exchange) required to achieve and maintain retinal reattachment will be recorded for each eye.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
Related trials for Retinal Detachment
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RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
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Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
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Retinal Detachment Prevention (Laser Prophylaxis) in Stickler Syndrome (SS)
Stickler Syndrome Type 1, Stickler Syndrome Type 2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing parsplana vitrectomy and adjunctive use of Methotrexate in people with Retinal Detachment, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity (time frame: 3 and 6 months after tamponade removal). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.